Pedicle screw systems and methods of assembling/installing the same

ABSTRACT

The pedicle screw system may be used for fixation of spinal segments and may be advantageous when minimally invasive surgery (MIS) techniques are employed. The pedicle screw system includes a tulip assembly comprising of a tulip body, an inner member, and an expansion member. Installation of the pedicle screw system into pedicles of the spine, for example, includes inserting the pedicle screw into a portion of the spine and then coupling the tulip assembly to the pedicle screw. The tulip assembly may be locked onto the pedicle screw before a distraction rod is placed in the tulip assembly. After the rod is placed in the tulip assembly, the tulip body and the inner member can be rotated relative to one another to lock the rod into the tulip assembly. In addition, the relative rotation may also provide additional locking of the tulip assembly to the pedicle screw.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.11/258,831 filed Oct. 25, 2005, now issued as U.S. Pat. No. 7,662,172,and claims the benefit under 35 U.S.C. §119(e) of U.S. ProvisionalPatent Application Nos. 60/622,107 filed Oct. 25, 2004; 60/622,180 filedOct. 25, 2004; 60/629,785 filed Nov. 19, 2004; 60/663,092 filed Mar. 18,2005; and 60/684,697 filed May 25, 2005, where these provisionalapplications are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to bone fixation devices, and inparticular to a screw assembly for the internal fixation of vertebralbodies.

2. Description of the Related Art

Various devices for internal fixation of bone segments in the human oranimal body are known in the art. One type of system is a pedicle screwsystem, which is sometimes used as an adjunct to spinal fusion surgery,and which provides a means of gripping a spinal segment. A conventionalpedicle screw system comprises a pedicle screw and a rod-receivingdevice. The pedicle screw includes an externally threaded stem and ahead portion. The rod-receiving device couples to the head portion ofthe pedicle screw and receives a rod (commonly referred to as adistraction rod). Two such systems are inserted into respectivevertebrae and adjusted to distract and/or stabilize a spinal column, forinstance during an operation to correct a herniated disk. The pediclescrew does not, by itself, fixate the spinal segment, but insteadoperates as an anchor point to receive the rod-receiving device, whichin turn receives the rod. One goal of such a system is to substantiallyreduce and/or prevent relative motion between the spinal segments thatare being fused.

Although conventional prior art pedicle screw systems exist, they lackfeatures that enhance and/or benefit newer, minimally invasive surgery(MIS) techniques that are more commonly being used for spinal surgeries.It has been suggested that one possible advantage of an MIS approach isthat it can decrease a patient's recovery time.

Conventional pedicle screw systems and even more recently designedpedicle screw systems have several drawbacks. Some of these pediclescrew systems are rather large and bulky, which may result in moretissue damage in and around the surgical site when the pedicle screwsystem is installed during surgery. The prior art pedicle screw systemshave a rod-receiving device that is pre-operatively coupled or attachedto the pedicle screw. In addition, some of the prior art pedicle screwsystems include numerous components that must all be carefully assembledtogether. For example, one type of pedicle screw system that may requireup to nine (9) different components is disclosed in U.S. PublishedPatent Application Nos. 2005/0203516 and 2005/0216003 to Biedermann etal.

One drawback that is common among many prior art pedicle screw systemsis that a threaded component is used to lock down the rod in therod-receiving device. Examples of these types of systems can be found inU.S. Published Patent Application Nos. 2005/0192571 to Abdelgany;2005/0192573 to Abdelgany et al.; the Biedermann et al. applications;2005/0187548 to Butler et al.; 2005/0203515 to Doherty et al.; and2004/0172022 to Landry et al. Each of these pedicle screw systems havean externally threaded fastening element either directly or indirectlycoupled to the vertically extending walls of the rod-receiving device(e.g., referred to as a bone fixator, a receiving part, a couplingconstruct, etc.).

One problem associated with the above-identified pedicle screw systemsis that cross-threading may occur when the fastening element isinstalled. Cross-threading may cause the fastening element to jam and/ormay result in an improper construct where some components may not be inthe correct position. Due to the dynamic nature of spinal movement, across-threaded pedicle screw system may be more prone to post-operativefailure.

Another problem with the above-identified pedicle screw systems is thatthe coupling between the fastening element and the rod-receiving devicewhen subjected to dynamic, post-operative loading may result in thewalls of the rod-receiving device splaying apart. In theabove-identified pedicle screw systems, the walls of the rod-receivingdevice are unsupported. Post-operative tulip splaying, as it is commonlycalled, may result in the dislodgment of the fastening element and therod. In short, the pedicle screw system may become post-operativelydisassembled and no longer function according to its intended purpose.

Other prior art pedicle screw systems have attempted to address some ofthe aforementioned drawbacks. For example, U.S. Pat. Nos. 5,609,593,5,647,873, 5,667,508, 5,669,911, and 5,690,630, all to Errico et al.,disclose a threaded, outer cap that extends over and couples to thewalls of the rod-receiving device. However, the risk and/or potentialfor cross-threading is still present when the threaded, outer cap iscoupled with the rod-receiving device.

Other pedicle screw systems such as U.S. Pat. No. 5,882,350 to Ralph etal.; U.S. Pat. No. 6,132,432 to Richelsoph; U.S. Pat. No. 4,950,269 toGaines, Jr.; U.S. Pat. No. 6,626,908 to Cooper et al.; U.S. Pat. No.6,402,752 to Schaffler-Wachter et al.; and U.S. Pat. No. 6,843,791 toSerhan may address some of the aforementioned drawbacks, but each ofthese pedicle screw systems are pre-operatively assembled, which makesthese systems more difficult to install and maneuver in a spinaloperation where MIS techniques are used.

BRIEF SUMMARY OF THE INVENTION

The invention is related to a bone fixation assembly, such as a pediclescrew system for the internal fixation of vertebral bodies. The pediclescrew system may be used for fixation of spinal segments and may beadvantageous when minimally invasive surgery (MIS) techniques areemployed. The pedicle screw system includes a tulip assembly comprisinga tulip body, an inner member, and an expansion member. Installation ofthe pedicle screw system into pedicles of the spine, for example,includes inserting the pedicle screw into a portion of the spine andthen coupling the tulip assembly to the pedicle screw. The tulipassembly may be locked onto the pedicle screw before a distraction rodis placed in the tulip assembly, after the distraction rod has beenplaced in the tulip assembly, but not yet locked therewith, or after thedistraction rod has been placed in the tulip assembly and lockedtherewith. The tulip body and the inner member can be rotated relativeto one another to lock the rod into the tulip assembly. In addition, therelative rotation may also provide additional locking of the tulipassembly to the pedicle screw.

In one aspect, a tulip assembly is coupled to a pedicle screw that has athreaded portion and a head portion. The tulip assembly includes a firstdevice elastically expandable to receive the head portion of the pediclescrew; and a second device having a rod-receiving portion and anengagement portion, the engagement portion engageable with the firstdevice to fix the tulip assembly to the head portion of the pediclescrew.

In another aspect, a pedicle screw system includes a pedicle screwhaving a threaded portion and a head portion; and a tulip assemblycomprising a first device and a second device, the first deviceelastically expandable to receive the head portion of the pedicle screw,and the second device having a rod-receiving portion and an engagementportion, the engagement portion engageable with the first device to fixthe tulip assembly to the head portion of the pedicle screw.

In yet another aspect, a method of fixing a tulip assembly to a pediclescrew includes inserting the pedicle screw into bone, where the pediclescrew includes a head portion with a maximum diameter section; expandinga first device over and past the maximum diameter section of the pediclescrew after the pedicle screw is inserted into the bone; seating aninner surface of the first device against the head portion of thepedicle screw; and urging a portion of a second device into contact witha portion of the first device to fix the tulip assembly to the pediclescrew.

In still yet another aspect, a method of fixing a rod to a pedicle screwsystem, Where the system includes a tulip assembly and a pedicle screw,includes inserting the pedicle screw into bone, the pedicle screw havinga head portion that includes a maximum diameter section; coupling thetulip assembly to the pedicle screw by expanding a first device over andpast the maximum diameter section of the pedicle screw, seating an innersurface of the first device against the head portion of the pediclescrew, and then urging a portion of a second device into contact with aportion of the first device to fix the tulip assembly to the pediclescrew; inserting a rod into the tulip assembly; and positioning a thirddevice relative to the second device to fix at least a portion of therod in the tulip assembly.

In still yet another aspect, a pedicle screw system includes a pediclescrew having a threaded portion and a spherical head portion; apoly-axial tulip assembly having a bore for accommodating the passage ofthe spherical head portion of the screw therethrough, the tulip assemblyhaving an inner component, an outer component and a fastener assembly,the tulip assembly positioned on the head portion of the screw; whereinthe fastener assembly is tapered along a top and a bottom edge, whereinan inner bore of the inner component is reciprocally tapered such thatthe fastener assembly mates with the inner component to allow the tulipassembly to be locked onto the head portion of the screw while allowingthe tulip assembly to move poly-axially in relation to the screw; andwherein the outer component includes a retaining member along a top edgefor receivably retaining the inner component in an engaged position,wherein the inner component lowered into a retained position locks anorientation of the tulip assembly relative to the screw.

In yet another aspect, a pedicle screw system includes a pedicle screwhaving a threaded portion and a spherical head portion; a poly-axialhousing positioned on the head portion of the screw, the housing havingan inner component, an outer component and a fastener assembly; whereinthe fastener assembly is tapered along a top and a bottom edge andwherein an inner bore of the inner component is reciprocally taperedsuch that the fastener assembly mates with the inner component to allowthe housing to be locked onto the head portion of the screw whileallowing the housing to move poly-axially in relation to the screw; andwherein the fastener assembly includes pockets along an edge adjacent tothe inner component, an edge of the inner component adjacent to thefastener assembly having reciprocal inclined planes for receivablyretaining the inner component in an engaged position, wherein partiallyrotating the inner component provides a provisional rotational lock ofthe housing to the screw.

In another aspect, a pedicle screw includes a screw having threads and ahead; a tulip coupled to the screw; a fastener internal to the tulip andpositioned to couple the tulip to the screw; and an inner component ofthe tulip, the inner component of the tulip longitudinally moveable toengage the screw to provide a poly-axial lock between the tulip and thescrew.

In yet another aspect, a method of connecting a rod to a pedicle screwsystem includes threading a screw having a head into bone of a patient;attaching a tulip assembly to the head of the screw; depressing a tulipinner component to lock the tulip to the screw; placing a rod into achannel of the tulip; and rotating the tulip inner component to capturethe rod.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn, are notintended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings. In addition, identical reference numbersidentify similar elements or acts.

FIG. 1 is an isometric view of a pedicle screw system, according to oneillustrated embodiment.

FIG. 2 is a side elevational view of a pedicle screw having a variableminor diameter, according to one illustrated embodiment.

FIG. 3 is an isometric view of a tulip assembly of the pedicle screwsystem of FIG. 1.

FIG. 4 is an isometric, exploded view of the tulip assembly of FIG. 3.

FIG. 5 is partial, cross-sectional view of a split ring and tulip bodyof the tulip assembly of FIG. 3.

FIG. 6 is an isometric view of an inner member of the tulip assembly ofFIG. 3.

FIGS. 7A-7D are isometric views of a method of installing a pediclescrew system into bone, according to the illustrated embodiments.

FIG. 8 is a side elevational view of a pedicle screw system, accordingto another illustrated embodiment.

FIG. 9 is an isometric, exploded view of a tulip assembly of the pediclescrew system FIG. 8.

FIG. 10 is a side elevational view of a pedicle screw system, accordingto another illustrated embodiment.

FIG. 11 is an isometric, exploded view of a tulip assembly and a pediclescrew of the pedicle screw system FIG. 10.

DETAILED DESCRIPTION OF THE INVENTION

By way of example, pedicle screw systems may be fixed in the spine in aposterior lumbar fusion process via minimally invasive surgery (MIS)techniques. The systems are inserted into the pedicles of the spine andthen interconnected with rods to manipulate (e.g., correct thecurvature, compress or expand, and/or structurally reinforce) at leastportions of the spine. Using the MIS approach to spinal fixation and/orcorrection surgery has been shown to decrease a patient's recovery timeand reduce the risks of follow-up surgeries.

The ability to efficiently perform spinal fixation and/or correctionsurgeries using MIS techniques is enhanced by the use of pedicle screwsystems provided in accordance with the present invention, which systemsprovide many advantages over conventional systems. For example, apedicle screw system in accordance with one embodiment provides theadvantage that the pedicle screw may be inserted into the bone withoutbeing pre-operatively coupled with the rod-coupling assembly(hereinafter referred to as a tulip assembly). This is advantageousbecause the surgeon often needs to do other inter-body work afterinserting the pedicle screw, but before attaching the larger and bulkiertulip assembly. Such an advantageous pedicle screw system may be evenmore crucial when using MIS techniques because the inter-body spatialboundaries in which the surgeon must work may be quite limited.

In addition, pedicle screw systems in accordance with the presentinvention advantageously allow a user to initially fix (e.g., lock) thetulip assembly to the pedicle screw at a desired angle before insertingand/or capturing the rod. Initially locking the tulip assembly to thepedicle screw means that at least one of the components of the tulipassembly is manipulated to grip and/or clamp onto the pedicle screw toreduce, if not prevent any translational and/or rotational movement ofthe tulip assembly relative to the pedicle screw. The ability toinitially lock the tulip assembly to the pedicle screw may facilitatethe surgeon in performing compression and/or distraction of variousspinal and/or bone sections.

The term “distraction,” when used in a medical sense, generally relatesto joint surfaces and suggests that the joint surfaces moveperpendicular to one another. However when “traction” and/or“distraction” is performed, for example on spinal sections, the spinalsections may move relative to one another through a combination ofdistraction and gliding, and/or other degrees of freedom.

Another advantageous feature of at least one embodiment of a pediclescrew system is to have an all-inclusive tulip assembly that can becoupled to the head portion of the pedicle screw intra-operatively. Thisadvantageous tulip assembly may include the aspects or features thatenable the tulip assembly to be initially locked onto the head portionof the pedicle screw and then to further receive, capture, and finallylock the rod into the tulip assembly. In one embodiment, the tulipassembly is initially locked onto the head portion of the pedicle screwafter the rod has been received in the tulip assembly. This advantageoustulip assembly may decrease the complexity of the pedicle screw systeminstallation by reducing the installation to essentially a three-stepprocess, which is inserting the pedicle screw into bone, initiallylocking the tulip assembly onto the pedicle screw, which may beaccomplished with or without the rod in the tulip assembly, and thencapturing and locking the rod into the tulip assembly.

In addition to accommodating the new MIS approach to spinal correctionand/or fusion, at least one pedicle screw system described herein mayinclude features to prevent, or at least reduce, the problems ofcross-threading and/or post-operative tulip splaying, which is when theamount of stress/strain in rod, which may be caused by post-operativeback flexion, forces open the tulip assembly and eventually leads to thedisassembly and/or the failure of the pedicle screw system.

Pedicle Screw System

FIG. 1 generally shows a pedicle screw system 100 comprising a pediclescrew 102, a rod 104, and a coupling assembly or tulip assembly 106,hereinafter referred to as a tulip assembly 106. The placement and/ornumber of pedicle screw systems 100 for a patient may be pre-operativelydetermined based on a pre-operative examination of the patient's spinalsystem using non-invasive imaging techniques known in the art, such asx-ray imaging, magnetic resonance imaging (MRI), and/or fluoroscopyimaging, for example. The tulip assembly 106 may be intra-operatively(i.e., during surgery) coupled to the pedicle screw 102 and maneuverableto achieve a desired placement, orientation, and/or angular position ofthe tulip assembly 106 relative to the pedicle screw 102. Once the tulipassembly 106 is at the desired position relative to the pedicle screw102, the tulip assembly 106 can be fixed or locked onto the pediclescrew 102. In one embodiment, the tulip assembly 106 is fixed onto thepedicle screw 102 before the rod is fixed or locked into the tulipassembly 106. In another embodiment, the tulip assembly 106 is fixedonto the pedicle screw 102 contemporaneously as the rod is fixed orlocked into the tulip assembly 106.

It is understood that the relative, angular position 107 of a firsttulip assembly 106 to a first pedicle screw 102 may be different fromother pedicle screw systems 100 located elsewhere on a patient's spine.In general, the relative, angular position 107 of the tulip assembly 106to the pedicle screw 102 allows the surgeon to selectively andindependently orient and manipulate the tulip assemblies 106 of eachpedicle screw system 100 installed into the patient to achieve and/oroptimize the goals of the surgical procedure, which may involvecompressing, expanding, distracting, rotating, reinforcing, and/orotherwise correcting an alignment of at least a portion of a patient'sspine.

FIG. 2 shows the pedicle screw 102 having an elongated, threaded portion108 and a head portion 110. Although pedicle screws 102 are generallyknown in the art, the head portions 110 may be of varying configurationsdepending on what type of tulip assembly 106 is to be coupled to thepedicle screw 102. The head portion 110 of the pedicle screw 102includes a driving feature 124 and a maximum diameter portion 126. Thedriving feature 124 permits the pedicle screw 102 to be inserted into apedicle bone and/or other bone. The pedicle bone is a part of a vertebrathat connects the lamina with a vertebral body. The driving feature 124can be used to adjust the pedicle screw 102 even after the tulipassembly 106 is coupled to the pedicle screw 102. In the illustratedembodiment, the head portion 110 of the pedicle screw 102 is coupled tothe threaded portion 108 and includes a generally spherical surface 127with a truncated or flat top surface 128.

In one embodiment, the pedicle screw 102 is cannulated, which means achannel 130 (shown in dashed lines and extending axially through thepedicle screw 102) extends through the entire length of the pediclescrew 102. The channel 130 allows the pedicle screw 102 to be maneuveredover and receive a Kirschner wire, commonly referred to as a K-wire. TheK-wire is typically pre-positioned using imaging techniques, forexample, fluoroscopy imaging.

FIGS. 3 and 4 show the tulip assembly 106 that includes a first memberor tulip body 132, an inner member or inner member 134, and anexpansion/contraction member or split ring 136, according to oneillustrated embodiment. The tulip body 132 includes a bore 138, an upperportion 140, a lower portion 142, and an internal lip 143. In oneembodiment, the tulip body 132, the inner member 134, and the split ring136 are pre-operatively assembled before being placed onto the headportion 110 of the pedicle screw 102. Both the inner member 134 and thesplit ring 136 may be inserted into the tulip body 132 through the bore138 upward or through the lower portion 142 of the tulip body 132.

FIG. 5 shows the split ring 136 inserted in the lower portion 142 of thetulip body 132. For purposes of clarity, the upper portion 140 of thetulip body, the pedicle screw 102, and the inner member 134 are notshown. An inner surface 144 of the bore 138 through the lower portion142 of the tulip body 132 is sized to allow the split ring 136 to floatand/or translate upwards so that the split ring 136 can expand toreceive the head portion 110 of the pedicle screw 102. The split ring136 includes an outer surface 146 and an inner surface 148. The outersurface 146 of the split ring 136 frictionally contacts the innersurface 144 of the bore 138 of the tulip body 132. The inner surface 148of the split ring 136 frictionally engages the head portion 110 of thepedicle screw 102, as will be described in more detail below. In oneembodiment, the split ring 136 is fabricated to be elasticallyexpandable and contractible within the range of operations describedherein.

FIG. 6 shows the inner member 134 having an outer diameter 150, acontoured channel 152 formed by extending arms 154, which includes arod-support surface or channel wall 156, and a bottom surface 158. Theouter inner diameter 150 is sized to be received in the bore 138 of thetulip body 132 and then be rotatable within the tulip body 132, as willbe described in more detail below. The contoured channel 152, along withthe rod-support surface 156, operates in cooperation with the tulip body132 to receive, capture, and eventually lock the rod 104 into the tulipassembly. The bottom surface 158 operates to engage the split ring 136and force the split ring 136 down in the bore 138 of the tulip body 132,which results in contraction of the split ring 136 around the headportion 110 of the pedicle screw 102. It is understood that the forcedcontraction of the split ring 136 along with the radial constraintprovided by the inner surface 144 of the tulip body 132 generatessufficient radial pressure on the head portion 110 of the pedicle screw102 to lock the tulip body 132 onto the pedicle screw 102.

Pedicle Screw System Installation

FIGS. 7A-7C show various stages of assembly and/or installation of thetulip assembly 106 to the pedicle screw 102. In the illustratedembodiments, the pedicle screw 102 has already been inserted into bonematerial 160. In FIG. 7A, the tulip assembly 106 is snapped onto thehead portion 110 of the pedicle screw 102. The inner surface 148 of thesplit ring 136 mates with the head portion 110 of the pedicle screw 102.As the tulip assembly 106 is pushed onto the head portion 110 of thepedicle screw 102, the split ring 136 expands and snaps onto the headportion 110. The split ring 136 is initially pushed up into the bore 138of the tulip body 132, as described above. The bore 138 in the lowerportion 142 of the tulip body 132 permits the split ring 136 to float inthe bore 138. Alternatively stated, as the split ring 136 is pushedupwards inside of the tulip body 132 by the head portion 110 of thepedicle screw, sufficient clearance is present for the split ring 136 toexpand and snap around the head portion 110 of the screw 102. At thispoint, the tulip assembly 106 is rotationally coupled to the headportion 110 of the pedicle screw 102. The tulip assembly 106 may berotated to achieve a desired orientation with respect to the pediclescrew 102 and the initial coupling mechanisms just described reduce thelikelihood that the tulip assembly 106 will be detached from the pediclescrew 102 during manipulation thereof.

Next, the mating tapered surfaces, which comprise the head portion 110of the pedicle screw 102, the outer and inner surfaces 146, 148 of thesplit ring 136, and the inner surface 144 of the lower portion of thebore 138 of the tulip body 132, cooperate to lock the tulip assembly 106onto the head portion 110 of the pedicle screw. An upward force appliedto the tulip body 132 tends to cause further compression and/orcontraction of the split ring 136 because the split ring 136 is forceddown further along the inner surface 144 of the bore 138 of the tulipbody 132. Such additional compression and/or contraction of the splitring 136 substantially locks or fixes the tulip assembly 106 onto thepedicle screw 102, thus preventing additionally rotation, manipulation,loosening, and/or removal of the tulip assembly 106 with respect to thepedicle screw 102. In short, when the tulip assembly 106 is initiallyplaced onto the head portion 110 of the pedicle screw 102, the tulipassembly 106 is free to move poly-axially in relation to the pediclescrew 102. Thus, the tulip assembly 106 remains free to rotate on thepedicle screw 102 until it is locked onto the head portion 110 of thepedicle screw 102, where the locking will be described below. Inaddition, both the tulip body 132 and the inner member 134 are alignedto receive the rod 104. For purposes of clarity, however, the rod 104 isnot shown so that the features of the tulip assembly 106 that captureand lock the rod 104 are more readily viewable.

FIG. 7B shows that the tulip body 132 and the inner member 134 arerotated, about a common axis, to begin capturing the rod 104. In oneembodiment, the inner member 134 is held while the tulip body 132 isrotated. In another embodiment, the tulip body 132 is held while theinner member 134 is rotated. In yet another embodiment, the inner member134 and the tulip body 132 are rotated relative to one another, withboth components being rotated at the same time. The tulip body 132includes extensions 162 that cooperate with the contoured channel 152and arms 154 of the inner member 134 to begin the capture of the rod104.

In addition, the inner member 134 may be rotated clockwise to retain therod 104 and/or the tulip body 132 rotated counterclockwise.Alternatively the inner member 134 may be rotated counterclockwiseand/or the tulip body 132 may be rotated clockwise. The rod 104 isinitially retained on the contoured surface 156 of the inner member 134,which includes a rod-capturing portion 164 (best shown in FIG. 7D). Theinner member 134 cooperates with the bore 138 of the tulip body 132 tocapture the rod 104. In addition, the inner member 134, after beingrotated relative to the tulip body 132 to capture the rod 104, providesstructural reinforcement to the tulip body 132 to prevent the tulip body132 from splaying open under post-operative dynamic and static loading,for example.

As shown in FIGS. 7A and 7B, the arms 154 of the inner member 134 areflexed inwards and protrude above the top surface of the tulip body 132.In FIG. 7C, the inner member 134 is forced or pushed down into the tulipbody 132 so that the top portion of the inner member 134 isapproximately flush with the top portion of the tulip body 132. Anadditional or continued downward force on the inner member 134 causesthe inner member 134 to snap or engage under the lip 143 located in theupper portion 140 of the tulip body 132. Hence, the elasticity of thearms 154 of the inner member 134 permit the arms to flex inward whenpushed down and then expand to become engaged under the lip 143 of thetulip body 132. This longitudinal engagement to retain the inner member134 within the tulip body 132 may be accomplished either before or afterthe rod 104 is placed in the tulip assembly 106. In one embodiment,forcing the inner member 134 down into the tulip body 132 may provideadditional locking capacity of the tulip assembly 106 onto the pediclescrew 102 because the bottom surface 158 of the inner member 134 pushesthe split ring 136 even further down along the inner surface 144 of thebore 138 of the tulip body 132. As described above, this action clampsthe tulip assembly 106 onto the head portion 110 of the pedicle screw.

In an alternate embodiment, forcing the inner member 134 down into thetulip body 132 may provide the initial locking of the tulip assembly 106onto the pedicle screw 102. Depending on the configuration of therelative, interacting surfaces, and possibly other factors, the processof forcing the inner member 134 downward to be retained in tulip body132 may, according to one embodiment, establish the initial lock of thetulip assembly 106 to the pedicle screw 102.

FIG. 7D shows the tulip assembly 106 in a locked or closed positionwhere the rod 104 is locked into the tulip assembly 106. As shown in theillustrated embodiment, a slight overlap occurs between the extensions162 of the tulip body 132 and the arms 154 of the inner member 134. Theadditional amount of relative rotation illustrated from FIGS. 7C to 7Dcompletes the rod-locking process to securely lock the rod 104 in thetulip assembly 106, according to the illustrated embodiment.

FIGS. 8 through 14 show alternative embodiments of pedicle screwsystems. These alternative embodiments, and other alternatives describedherein, are substantially similar to previously described embodiments.Structural aspects and/or features and assembly/installation steps thatare common to the previously described embodiments are identified bylike reference numbers. Only significant differences in operation andstructure are described below.

FIGS. 8 and 9 show an alternative embodiment of a pedicle screw system200, according to the illustrated embodiment. The pedicle screw system200 includes the pedicle screw 102 with an alternative tulip assembly202. The alternative tulip assembly 202 comprises a tulip body 204, aninner member 206, and an expansion member or split ring 208. In theillustrated embodiment, the inner member 206 includes inclined planes210 to provide a different method and structure for initially lockingthe angle of the alternative tulip assembly 202 to the pedicle screw102. The initial locking is achieved by rotating the inner member 206partially through its allowable rotation. The inclined planes 210 of theinner member 206 engage with pockets 212 present in the expansion member208. The inclined planes 210 operate as cam extensions on the innermember 206 to force the expansion member 208 downward and into a tightcompression, thus locking the alternative tulip assembly 202 onto thehead portion 110 of the pedicle screw 102.

FIGS. 10 and 11 show a pedicle screw system 300 in accordance with yetanother embodiment. FIG. 11 is an exploded view of the pedicle screwsystem 300 of FIG. 10. The pedicle screw system 300 includes a pediclescrew 302 and a tulip assembly 304. The pedicle screw 302 includes adual diameter head portion 306. The tulip assembly 304 includes a tulipbody or body 308, an inner member or second device 310, and an expansionmember, split ring or first device 312.

According to aspects of the illustrated embodiment, the rod (not shown)is captured and then subsequently locked by rotating the inner member310. An initial lock is achieved between the tulip assembly 304 and thepedicle screw 302 by pushing the inner member 310 down into the tulipbody 308. Barbed surfaces 314 on the inner member 310 engage barbedsurfaces in the tulip body 308 to retain the inner member 310 inside thetulip body 308. The inner member 310, in turn, pushes on the split ring312 to lock the tulip assembly 304 onto the pedicle screw 302. Inaddition, inclined planes (not shown) may be located on the arms 316 ofthe inner member 310 to force the rod tightly against a first rod slotor channel 318 in the inner member 310 and/or in a second rod slot orchannel 320 in the tulip body 308. Thus, the rotation of the innermember 310 relative to the tulip body 308 locks the rod in the tulipassembly 304.

In operation, the pedicle screw systems as described, but not limited tothe embodiments herein, are designed for fixation of bone materialand/or bone segments during a surgical procedure, such as fusing spinalsegments in which MIS techniques are employed. For example, the pediclescrew system is inserted into the pedicles of the spine and theninterconnected with rods to provide support to the spine to allow forpost-operative fusion of the spinal segments. While the pedicle screwcan be inserted with the tulip assembly coupled with the pedicle screw,one embodiment for the installation of the pedicle screw system includesinserting the pedicle screw into the bone and subsequently coupling thetulip assembly to the pedicle screw, where such an approach hasadvantages over currently known pedicle screw system assemblies and/orinstallations.

In addition, various structural features of the pedicle screw systems asdescribed, but not limited to the embodiments herein, may provide otheradvantages over existing pedicle screw systems. First, the pedicle screwmay be inserted into the bone without the presence of the tulip assemblyor rod, which permits the surgeon to place the screw and then performsubsequent inter-body work without having to work around the tulipassembly or the rod. Second, the tulip assembly includes a mechanism forcapturing the rod that eliminates problems associated with conventionalpedicle screws, such as cross-threading, because the pedicle screwsystems disclosed herein do not use any threads to couple the tulipassembly to the pedicle screw or to capture and lock the rod into thetulip assembly. Third, the interface between the head portion of thepedicle screw and the tulip assembly provides an initial lock, whichallows the angle of the tulip assembly to be set or fixed with respectto the pedicle screw before insertion of the rod and/or before the rodis captured in the tulip assembly. With this type of pedicle screwsystem, the surgeon has the ability to check and even double check theplacement, angle, and/or orientation regarding aspects of the pediclescrew system to facilitate, and even optimize, the compression,distraction, and/or other manipulation of the spinal segments. Further,the pedicle screw systems accommodate the new MIS techniques beingapplied to spinal operations.

One possible post-operative advantage of the pedicle screw systems isthat the cooperation and interaction of the inner member with the tulipbody of the tulip assembly substantially reduces and most likelyprevents the known problem of tulip splaying. Tulip splaying isgenerally regarded as a post-operative problem of when a stressed rodforces open portions of the tulip body, which eventually leads to thedisassembly and likely failure of the pedicle screw system within thepatient. Yet another post-operative advantage of the pedicle screwsystems is that unlike existing rod-coupling members or constructs, thetulip assemblies described herein have a smaller size envelope (e.g.,less bulky, lower profile, and/or more compact shape) and are easier toplace onto the pedicle screw. The smaller size and ease of installationmay reduce trauma to the soft-tissue regions in the vicinity of thesurgical site, which in turn generally allows for a quicker recovery bythe patient.

Yet another possible advantage of the pedicle screw systems overexisting systems is that all of the parts needed to lock the tulipassembly to the pedicle screw and to capture and lock the rod into thetulip assembly are included within the tulip assembly. Accordingly, oncethe tulip assembly is snapped or otherwise coupled to the pedicle screw,no additional locking cap or threaded fastener is needed to complete theassembly/installation of the pedicle screw system. According to aspectsdescribed herein, and as appended by the claims, the inventive pediclescrew systems permit inserting the pedicle screw without the tulipassembly coupled thereto, locking the tulip assembly onto the pediclescrew, and subsequently capturing and locking the rod into the tulipassembly. The various embodiments described above can be combined toprovide further embodiments. All of the above U.S. patents, patentapplications, provisional patent applications and publications referredto in this specification, to include, but not limited to U.S.Provisional Patent Application Nos. 60/622,107 filed Oct. 25, 2004;60/622,180 filed Oct. 25, 2004; 60/629,785 filed Nov. 19, 2004;60/663,092 filed Mar. 18, 2005; and 60/684,697 filed May 25, 2005 areincorporated herein by reference in their entirety. Aspects of theinvention can be modified, if necessary, to employ various systems,devices and concepts of the various patents, applications andpublications to provide yet further embodiments of the invention.

These and other changes can be made to the invention in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification and the claims, butshould be construed to include all bone fixation systems and methodsthat operate in accordance with the claims.

Accordingly, the invention is not limited by the disclosure, but insteadits scope is to be determined entirely by the following claims.

1. A pedicle screw system comprising: a pedicle screw having a threadedportion and a head portion; and a tulip assembly comprising a bodyhaving a tapered bore, a first device and a second device situated insaid body, said first device being elastically expandable to receive thehead portion of the pedicle screw, said second device received in thebody and having an engagement portion, the engagement portion engageablewith the first device to fix the tulip assembly to the head portion ofthe pedicle screw by moving said first device generally longitudinallyin said tapered bore to cause said first device to compress about andlock onto said head portion in response to axial movement of said seconddevice; said at least one of said body or said second device comprisinga first surface and a generally opposing second surface that defines achannel having a first channel portion and a second channel portion thatis in communication with said first channel portion, said first channelportion defining a rod-receiving opening and extending in a firstdirection that is generally parallel to an axis of said tulip assemblyand said second channel portion generally transverse to said firstdirection; said first channel portion being adapted to receive a rod andguide said rod to said second channel portion so that said secondchannel portion can receive and lock said rod in said tulip assembly inresponse to a rotating of said at least one of said body or said seconddevice; said head portion of said pedicle screw, said first device andsaid second device are all inserted into said tapered bore of said bodyeither upwardly or through a lower portion of said body.
 2. The pediclescrew system of claim 1, further comprising: a third device coupled tothe second device, said second and third devices working in cooperationto selectively fix at least a portion of a rod in the tulip assembly. 3.The pedicle screw system of claim 1 wherein the tulip assembly isrotationally maneuverable on the head portion of the pedicle screwbefore the second device engages the first device.
 4. The pedicle screwsystem of claim 1 wherein the first device is a compressible ring thatis expandable to be moved over the head portion of the pedicle screw. 5.The pedicle screw system of claim 4 wherein the compressible ringincludes a split that permits a diameter of the compressible ring tovary from a first, larger diameter to a second, smaller diameter.
 6. Thepedicle screw system of claim 1 wherein the first device includes aninner surface to seat against the head portion of the pedicle screw. 7.The pedicle screw system of claim 1, wherein said inner componentcomprises said channel to permit said inner component to rotate withinsaid body to lock said rod to said body.
 8. The pedicle screw system ofclaim 1, wherein said body comprises said channel to permit said body torotate about said second device to lock said rod to said body.
 9. Apedicle screw comprising: a screw having threads and a head; a tulipcomprising a body having a tapered bore, said tulip coupled to thescrew; a fastener internal to the tulip and positioned to couple thetulip to the screw; and an inner component of the tulip, the innercomponent of the tulip being longitudinally moveable to engage the screwand to lock the tulip to the screw by moving said inner componentgenerally longitudinally in said tapered bore to cause said fastener tocompress about and lock onto said head in response to axial movement ofsaid inner component; at least one of said tulip or said inner componentcomprising a first surface and a generally opposing second surface thatdefines a channel having a first channel portion and a second channelportion that is in communication with said first channel portion, saidfirst channel portion defining a rod-receiving opening and extending ina first direction that is generally parallel to an axis of said tulipand said second channel portion generally transverse to said firstdirection; said first channel portion being adapted to receive a rod andguide said rod to said second channel portion so that said secondchannel portion can receive and lock said rod in said tulip in responseto a rotating of said at least one of said body or said inner component;a head portion of said pedicle screw, said fastener, and said innercomponent, are all inserted into said tapered bore of said body eitherupwardly or through a lower portion of said body.
 10. The pedicle screwaccording to claim 9 wherein the inner component is rotatable to retaina rod placed in a recess in the tulip.
 11. The pedicle screw accordingto claim 9 wherein the fastener includes at least one split that permitsthe diameter of the fastener to vary from a first, large diameter to asecond, small diameter.
 12. The pedicle screw according to claim 9wherein the tulip further includes a lip for longitudinally retainingthe inner component.
 13. The pedicle screw system of claim 9, whereinsaid inner component comprises said channel to permit said innercomponent to rotate within said body to lock said rod to said body. 14.The pedicle screw system of claim 1, wherein said body comprises saidchannel to permit said body to rotate about said second device to locksaid rod to said body.
 15. A pedicle screw comprising: a screw havingthreads and a head; a tulip comprising a body having a tapered bore; afastener internal to the tulip and positioned to couple the tulip to thescrew; and an inner component of the tulip being longitudinally moveableto engage the screw to lock the tulip to the screw by moving said innercomponent generally longitudinally in said tapered bore to cause saidfastener to compress about and lock onto said head in response to axialmovement of said inner component; wherein said tulip comprises arod-receiving end for receiving a rod and an opposite end, said oppositeend having an opening adapted to receive said fastener, said innercomponent and said head of said screw; at least one of said tulip orsaid inner component comprising a first surface and a generally opposingsecond surface that defines a channel having a first channel portion anda second channel portion that is in communication with said firstchannel portion, said first channel portion defining a rod-receivingopening and extending in a first direction that is generally parallel toan axis of said tulip and said second channel portion generallytransverse to said first direction; said first channel portion beingadapted to receive a rod and guide said rod to said second channelportion so that said second channel portion can receive and lock saidrod in said tulip in response to a rotating of said at least one of saidbody or said inner component; a head portion of said pedicle screw, saidfastener, and said inner component, are all inserted into said taperedbore of said body either upwardly or through a lower portion of saidbody.
 16. The pedicle screw according to claim 15 wherein the innercomponent is rotatable to retain a rod placed in a recess in the tulip.17. The pedicle screw according to claim 15 wherein the fastenerincludes at least one split ring that permits the diameter of thefastener to vary from a first, large diameter to a second, smalldiameter.
 18. The pedicle screw according to claim 15 wherein the tulipfurther includes a lip for longitudinally retaining the inner component.